Eisai wins US approval for chemotherapy side effects drug

FDA backs Akynzeo to treat nausea and vomiting

The US FDA has approved a new drug to treat nausea and vomiting related to cancer treatment with chemotherapy.

Eisai's Akynzeo (netupitant) is an oral combination of new drug netupitant and Aloxi (palonosetron) - a drug also marketed by Eisai that is approved to treat US cancer patients during the first 24 hours after the start of chemotherapy treatment, known as the acute phase.

Akynzeo is effective in both the acute phase and the delayed phase (up to 120 hours after chemotherapy), meaning the drug provides complementary treatment to Aloxi.

This effect was seen in two clinical trials that formed the basis of the FDA approval. Combined, these studies involved 1,720 people receiving chemotherapy, with groups split between those taking Akynzeo and those on Aloxi.

Results of the first study demonstrated that 98.5% of patients who took Akynzeo did not experience any vomiting or require extra support for nausea during the first 24 hours after receiving treatment. In the Aloxi arm of the trial that figure was 89.7%.

The study also recorded figures comparing the ability for Akynzeo and Aloxi to prevent vomiting and treat nausea in both the delayed and overall phase of chemothepray treatment. For Akynzeo the figures were 90.4% and 80.6% respectively, while for the Aloxi arm the figures were 80.1% and 76.5%.

The second trial showed similar results, according to the FDA.

“Supportive care products, such as Akynzeo, help ease the nausea and vomiting patients may experience as a side effect of cancer chemotherapy,” said Julie Beitz, who works for the FDA's Center for Drug Evaluation and Research.